Etanercept is an active pharmaceutical ingredient in the Tumor Necrosis Factor Alpha (Tnf-Alpha) Inhibitors group (L04AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised May 15, 2026[1]
Rheumatoid arthritis Nepexto in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Nepexto can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Nepexto is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Nepexto, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
CACanada· Health Canada
9 products
Uses
CAOfficial regulatory label· revised May 30, 2025[2]
ENBREL is indicated for: • treatment of moderately to severely active rheumatoid arthritis (RA) in adults. Treatment is effective in reducing the signs and symptoms of RA, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function.
ENBREL can be initiated in combination with methotrexate (MTX) in adult patients or used alone. • reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).
Efficacy and safety have not been established in children less than 4 years of age. • reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in adult patients with psoriatic arthritis (PsA).
ENBREL can be used in combination with methotrexate in adult patients who do not respond adequately to methotrexate alone. • reducing signs and symptoms of active ankylosing spondylitis (AS). • treatment of adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
EUEuropean Union· EMA
5 products
Uses
EUOfficial regulatory label· revised May 28, 2026[3]
Rheumatoid arthritis Fubelv in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Fubelv can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Fubelv is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults 3 not previously treated with methotrexate.
Fubelv, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Drug interactions
Known interactions involving Etanercept. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 306. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PLGB581410010 · revised May 15, 2026
[2]Health Canada (DPD) · 02274728 · revised May 30, 2025
[3]European Medicines Agency · EMEA/H/C/006738 · revised May 28, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Etanercept has not been studied in children aged less than 2 years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.
Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Axial spondyloarthritis Ankylosing spondylitis Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).
1). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
How to take
GBOfficial regulatory label· revised May 15, 2026[1]
Nepexto treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
Patients treated with Nepexto should be given the Patient Card. Nepexto is available in strengths of 25 and 50 mg. Posology Rheumatoid arthritis 25 mg etanercept administered twice weekly is the recommended dose. 1). Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly.
For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Plaque psoriasis The recommended dose of etanercept is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or a dose of 50 mg once weekly.
Treatment with Nepexto should continue until remission is achieved, for up to 24 weeks. 1). Treatment should be discontinued in patients who show no response after 12 weeks. If re-treatment with Nepexto is indicated, the same guidance on treatment duration should be followed.
The dose should be 25 mg twice weekly or 50 mg once weekly. Special populations Renal and hepatic impairment No dose adjustment is required. Elderly No dose adjustment is required. Posology and administration are the same as for adults 18-64 years of age.
Paediatric population Nepexto is only available as 25 mg pre-filled syringe, 50 mg pre-filled syringe and 50 mg pre-filled pen. Thus, it is not possible to administer Nepexto to paediatric patients that require less than a full 25 mg or 50 mg dose.
Paediatric patients who require a dose other than a full 25 mg or 50 mg should not receive Nepexto. If an alternate dose is required, other etanercept products offering such an option should be used. The dosage of etanercept is based on body weight for paediatric patients.
5 kg should be accurately dosed on a mg/kg basis using the powder and solvent for solution for injection presentations or powder for solution for injection presentations (see below for dosing for specific indications). 5 kg or more may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.
The safety and efficacy of etanercept in children aged less than 2 years has not been established. No data are available. 8 mg/kg (up to a maximum of 50 mg per dose) given once weekly. Discontinuation of treatment should be considered in patients who show no response after 4 months.
A 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg. No formal clinical trials have been conducted in children aged 2 to 3 years. 1). There is generally no applicable use of etanercept in children aged below 2 years in the indication juvenile idiopathic arthritis.
8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks. Treatment should be discontinued in patients who show no response after 12 weeks. If re-treatment with Nepexto is indicated, the above guidance on treatment duration should be followed.
8 mg/kg (up to a maximum of 50 mg per dose) once weekly. There is generally no applicable use of etanercept in children aged below 6 years in the indication plaque psoriasis. 6). Comprehensive instructions for administration are given in the package leaflet, section 7, “Instructions for use”.
Detailed instructions on unintentional dosing or scheduling variations, including missed doses, are provided in section 3 of the package leaflet.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 15, 2026[1]
Summary of the safety profile The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), headache, allergic reactions, development of autoantibodies, itching, and fever.
Serious adverse reactions have also been reported for etanercept. TNF-antagonists, such as etanercept, affect the immune system and their use may affect the body’s defenses against infection and cancer. Serious infections affect fewer than 1 in 100 patients treated with etanercept.
Reports have included fatal and life-threatening infections and sepsis. Various malignancies have also been reported with use of etanercept, including cancers of the breast, lung, skin and lymph glands (lymphoma). Serious haematological, neurological and autoimmune reactions have also been reported.
These include rare reports of pancytopenia and very rare reports of aplastic anaemia. Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with etanercept use. There have been rare reports of lupus, lupus- related conditions, and vasculitis.
Tabulated list of adverse reactions The following list of adverse reactions is based on experience from clinical trials in adults and on post -marketing experience. Within each System Organ Class, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
4) Respiratory, thoracic, and mediastinal disorders Interstitial lung disease (including pneumonitis and System Organ Class Very Common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very Rare <1/10,000 Not Known (Cannot be Estimated from Available Data) pulmonary fibrosis)* Gastrointestinal disorders Inflammatory bowel disease Hepatobiliary disorders Elevated liver enzymes* Autoimmune hepatitis* Skin and subcutaneous tissue disorders Pruritus, rash Angioedema, psoriasis (including new onset or worsening and pustular, primarily palms and soles), urticaria, psoriasiform rash Stevens- Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions Toxic epidermal necrolysis Musculoskeletal and connective tissue disorders Cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus, lupus-like syndrome Renal and urinary disorders Glomerulonephritis General disorders and administration site conditions Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)* Pyrexia * see Description of selected adverse reactions, below.
Description of selected adverse reactions Malignancies and lymphoproliferative disorders One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with etanercept for up to approximately 6 years, including 231 patients treated with etanercept in combination with methotrexate in the 2-year active controlled study.
The observed rates and incidences in these clinical trials were similar to those expected for the population studied. A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 etanercept-treated psoriatic arthritis patients.
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in etanercept-treated patients. 5 […]
GBOfficial regulatory label· Warnings and precautions· revised May 15, 2026[1]
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Patients should be evaluated for infections before, during, and after treatment with Nepexto, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
8). These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa). In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death.
, exposure to endemic mycoses) should be considered. Patients who develop a new infection while undergoing treatment with Nepexto should be monitored closely. Administration of Nepexto should be discontinued if a patient develops a serious infection.
The safety and efficacy of etanercept in patients with chronic infections have not been evaluated. Physicians should exercise caution when considering the use of Nepexto in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections, such as advanced or poorly controlled diabetes.
Tuberculosis Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with etanercept. Before starting treatment with Nepexto, all patients must be evaluated for both active and inactive (‘latent’) tuberculosis.
This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy. , tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
It is recommended that the conduct of these tests should be recorded in the Patient Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
If active tuberculosis is diagnosed, Nepexto therapy must not be initiated. If inactive (‘latent’) tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Nepexto, and in accordance with local recommendations.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 15, 2026[1]
1. Sepsis or risk of sepsis. Treatment with Nepexto should not be initiated in patients with active infections, including chronic or localised infections.
This is not medical advice. Consult a qualified healthcare professional.
• treatment of pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy. Data on safety and efficacy are limited in the age group 4 to 6 years. Improvement may be seen as early as 1 week after initial administration of ENBREL in adults, and within 2 weeks in children with JIA and 4 weeks in PsO.
Attainment of full effect was usually seen by 3 months in both populations and remained durable thereafter with continued treatment with ENBREL. Some patients see continuing improvement after 3 months of treatment with ENBREL. After discontinuation of ENBREL, symptoms of arthritis generally returned within a month.
Reintroduction of treatment with ENBREL in adults after discontinuation of up to 18 months resulted in the same magnitudes of response as patients who received ENBREL without interruption of therapy based on results of open-label studies.
Reintroduction of ENBREL to children with JIA after discontinuation up to 4 months also resulted in a subsequent response to therapy. 1 Pediatrics Efficacy and safety have not been established in children less than 4 years of age. ENBREL is indicated in the treatment of polyarticular JIA in patients ages 4 to 17 who have had an inadequate response to one or more DMARDs, and in patients ages 4 to 17 with chronic PsO who are candidates for systemic therapy or phototherapy.
Data on safety and efficacy in PsO patients are limited in the age group 4 to 6 years (see WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics). 2 Geriatrics Four hundred and eighty RA patients in clinical studies were age 65 or older.
No overall differences in safety or effectiveness were observed between these patients and younger patients. One hundred thirty-eight patients with PsO in clinical studies were age 65 or older. No overall differences in effectiveness were observed between younger and older patients with psoriasis.
Because there is greater sensitivity and predisposition of older individuals to infection, caution should be used in treating the elderly (see WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics).
How to take
CAOfficial regulatory label· revised May 30, 2025[2]
1 Dosing Considerations ENBREL (etanercept) is intended for use under the guidance and supervision of a physician who has sufficient knowledge of RA, JIA, PsA, AS, or PsO and who has fully familiarized themselves with the efficacy/safety profile of ENBREL.
Patients may self-inject only if their physician determines that it is appropriate and with medical follow-up, as necessary, after proper training in measurement of the correct dose and injection technique. The ENBREL prefilled syringe and prefilled autoinjector are not made with natural rubber latex.
2 Recommended Dose and Dosage Adjustment General A 50 mg dose should be given as one subcutaneous (SC) injection. A 50 mg dose can also be given as two 25 mg SC injections. When administering ENBREL as two 25 mg injections in adults or children, the injections should be given either on the same day once weekly or 3 or 4 days apart.
Adult Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis Patients The recommended dose of ENBREL for adult patients with RA, PsA, or AS is 50 mg per week. Methotrexate, glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with ENBREL.
Based on a study of 50 mg ENBREL twice weekly in patients with RA that suggested higher incidence of adverse reactions but similar American College of Rheumatology (ACR) response rates, doses higher than 50 mg per week are not recommended.
Adult Plaque Psoriasis Patients The recommended starting dose of ENBREL for adult patients is a 50 mg dose given twice weekly (administered 3 or 4 days apart) for 3 months followed by a reduction to a maintenance dose of 50 mg per week.
A maintenance dose of 50 mg given twice weekly has also been shown to be efficacious. Pediatric Patients (Juvenile Idiopathic Arthritis or Plaque Psoriasis) ENBREL should be administered by, or under the supervision of, a responsible adult.
8 mg/kg per week (up to a maximum of 50 mg per week). The 50 mg prefilled syringe or SureClick® autoinjector may be used for pediatric patients weighing 63 kg (138 pounds) or more. In JIA, glucocorticoids, NSAIDs, or analgesics may be continued during treatment with ENBREL.
ENBREL Product Monograph Page 7 of 85 Concurrent use with methotrexate and higher doses of ENBREL have not been studied in pediatric patients. 4 Administration Preparation of ENBREL Using the Single-use Prefilled Syringe or Single-use Prefilled SureClick® Autoinjector: Before injection, allow ENBREL to reach room temperature (approximately 15 to 30 minutes).
DO NOT remove the needle cover while allowing the prefilled syringe or SureClick® autoinjector to reach room temperature. Prior to administration, visually inspect the solution for particulate matter and discolouration. There may be small white particles of protein in the solution.
This is not unusual for proteinaceous solutions. The solution should not be used if discoloured or cloudy, or if foreign particulate matter is present. 5 Missed Dose Patients who miss a dose of ENBREL should be advised to inject their dose as soon as they remember, then take the next dose at the regular(ly) scheduled time.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised May 30, 2025[2]
1 Adverse Reaction Overview Adverse Reactions in Adult Patients with Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Plaque Psoriasis ENBREL has been studied in 1442 patients with RA who have been followed for over 6 years, including 225 patients who have been followed for more than 10 years.
ENBREL has been studied in 169 adult patients with PsA for up to 24 months, in 222 patients with AS for up to 48 months and in 1864 adult patients with PsO for up to 36 months. ENBREL has over four million patient-years of post-market exposure.
Among patients with RA treated in placebo-controlled studies, serious adverse events occurred at a frequency of 4% in 349 patients treated with ENBREL compared to 5% of 152 placebo-treated patients. In a subsequent study (Study III), serious adverse events occurred at a frequency of 6% in 415 patients treated with ENBREL compared to 8% of 217 methotrexate-treated patients.
In long-term open-label studies in adults with RA, there were no new or unexpected serious adverse events reported. Among adult patients with PsA, serious adverse events occurred at a frequency of 4% in 101 patients treated with ENBREL compared to 4% of 104 placebo-treated patients.
5% among ENBREL and placebo-treated patients in the first 3 months of treatment. However, in patients greater than 65 years of age treated with ENBREL 50 mg twice weekly, serious adverse events occurred at a higher rate than in younger patients.
In long-term open-label trials of adult PsO, serious non-infectious adverse events were infrequent and exposure-adjusted event rates generally remained stable throughout ENBREL treatment. Although data for patients aged 65 or greater in the long-term trials are limited, adverse events, including serious adverse events, occurred at a higher frequency for patients treated with 50 mg twice weekly.
Among RA patients in placebo-controlled, active-controlled, and open-label trials of ENBREL, infections and malignancies were the most common serious adverse events observed. Other infrequent serious adverse events observed in RA, PsA, AS or PsO clinical trials are listed below by body system: Cardiovascular: cardiomyopathy, fainting, heart failure, hypertension, hypotension, myocardial infarction, myocardial ischemia, deep vein thrombosis, thrombophlebitis Digestive: cholecystitis, diarrhea, esophageal ulcer, gastrointestinal hemorrhage, pancreatitis, appendicitis ENBREL Product Monograph Page 18 of 85 General: impaired healing, asthenia Hematologic/Lymphatic: lymphadenopathy, myelodysplastic syndrome, necrotizing granulomatous lymphadenitis Hepatic: hepatic disorder, hepatic steatosis Musculoskeletal: bursitis, fistula, fracture nonunion, polymyositis Nervous: anxiety, cerebral ischemia, convulsion, depression, multiple sclerosis Respiratory: asthma, dyspnea, pulmonary embolism, sarcoidosis Skin: worsening psoriasis Urogenital: membranous glomerulonephropathy, kidney calculus In a randomized controlled trial in which 51 patients with RA received ENBREL 50 mg twice weekly and 25 patients received ENBREL 25 mg twice weekly, the following serious adverse events were observed in the 50 mg twice weekly arm: gastrointestinal bleeding, normal pressure hydrocephalus, seizure, and stroke.
No serious adverse events were observed in the 25 mg arm. In controlled trials, the proportion of patients who discontinued treatment due to adverse events was approximately 4% in both the ENBREL and placebo treatment groups. The vast majority of these patients were treated with the recommended dose of 25 mg SC twice weekly.
In adult PsO studies, ENBREL doses studied were 25 mg SC once or twice a week and 50 mg SC once or twice a week. In three randomized, placebo-controlled studies of adult patients with PsO, the safety profile for patients receiving 50 mg twice a week was similar to those receiving 25 mg once or twice weekly, and all were similar to placebo.
No cumulative toxicities were observed in long term studies in adult patients with PsO up to 144 weeks and AS up to 192 weeks. 26%) placebo-treated patients. 49). In the long-term open-label RA studies, the rate of death did not increase over time with increasing exposure to ENBREL.
08%) ENBREL-treated patients compared to 0 of 720 placebo-treated patients. 25). No deaths were reported in PsA, AS, or JIA studies. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. ENBREL Product Monograph Page 19 of 85 Adverse reactions reported in at least 1% of all patients who received ENBREL in placebo- controlled RA trials (including the combination methotrexate trial) are outlined in Table 1 below.
Adverse reactions reported in JIA, adult PsA, AS, and adult PsO trials were similar to those reported in RA clinical trials. Table 1. Percent of Rheumatoid Arthritis Patients Reporting Adverse Reactions 1% by Body System and Preferred Term in Controlled Clinical […]
CAOfficial regulatory label· Warnings and precautions· revised May 30, 2025[2]
Please see the SERIOUS WARNINGS AND PRECAUTIONS BOX at the beginning of PART I:
HEALTH PROFESSIONAL INFORMATION. Serious and Opportunistic Infections Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic (including protozoal), or other opportunistic pathogens have been reported in patients receiving TNF-blocking agents.
Tuberculosis, histoplasmosis, aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, legionellosis, listeriosis, and pneumocystosis have been reported (see ADVERSE REACTIONS, Infections). Patients have frequently presented with disseminated rather than localized disease.
Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections. *25 mg single-use prefilled syringe is not available in Canada.
ENBREL Product Monograph Page 9 of 85 Treatment with ENBREL should not be initiated in patients with an active infection, including clinically important localized infections. The risks and benefits of treatment should be considered prior to initiating therapy in patients: • With chronic or recurrent infection; • Who have been exposed to tuberculosis; • With a history of an opportunistic infection; • Who have resided or traveled in areas of endemic tuberculosis or mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; • With underlying conditions that may predispose them to infection such as advanced or poorly controlled diabetes.
Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving ENBREL, including patients who have previously received treatment for latent or active tuberculosis. Patients should be evaluated according to the Canadian Tuberculosis Standards guidelines for tuberculosis risk factors and tested for latent infection prior to initiating ENBREL and during therapy as appropriate.
Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immuno-compromised. If active tuberculosis is diagnosed, ENBREL therapy should not be initiated. If inactive (‘latent’) tuberculosis is diagnosed, treatment should be started with anti-tuberculosis therapy before the initiation of ENBREL.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised May 30, 2025[2]
• ENBREL is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Patients with, or at risk of, sepsis syndrome, such as immunocompromised and HIV+ patients.
This is not medical advice. Consult a qualified healthcare professional.
Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease- modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Axial spondyloarthritis Ankylosing spondylitis Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).
1). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
How to take
EUOfficial regulatory label· revised May 28, 2026[3]
Fubelv treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
Patients treated with Fubelv should be given the Patient Card. 4 Fubelv is available in strengths of 25 and 50 mg. Posology Rheumatoid arthritis 25 mg etanercept administered twice weekly is the recommended dose. 1). Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly.
For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Plaque psoriasis The recommended dose of etanercept is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or a dose of 50 mg once weekly.
Treatment with Fubelv should continue until remission is achieved, for up to 24 weeks. 1). Treatment should be discontinued in patients who show no response after 12 weeks. If re-treatment with Fubelv is indicated, the same guidance on treatment duration should be followed.
The dose should be 25 mg twice weekly or 50 mg once weekly. Special populations Renal and hepatic impairment No dose adjustment is required. Elderly No dose adjustment is required. Posology and administration are the same as for adults 18-64 years of age.
Paediatric population Fubelv is only available as 25 mg pre-filled syringe, 50 mg pre-filled syringe and 50 mg pre-filled pen. Thus, it is not possible to administer Fubelv to paediatric patients that require less than a full 25 mg or 50 mg dose.
Paediatric patients who require a dose other than a full 25 mg or 50 mg should not receive Fubelv. If an alternate dose is required, other etanercept products offering such an option should be used. The dosage of etanercept is based on body weight for paediatric patients.
5 kg should be accurately dosed on a mg/kg basis using the powder and solvent for solution for injection presentations or powder for solution for injection presentations (see below for dosing for specific indications). 5 kg or more may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.
The safety and efficacy of etanercept in children aged less than 2 years has not been established. No data are available. 8 mg/kg (up to a maximum of 50 mg per dose) given once weekly. Discontinuation of treatment should be considered in patients who show no response after 4 months.
A 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg. No formal clinical trials have been conducted in children aged 2 to 3 years. 1). There is generally no applicable use of etanercept in children aged below 2 years in the indication juvenile idiopathic arthritis.
8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks. Treatment should be discontinued in patients who show no response after 12 weeks. If re-treatment with Fubelv is indicated, the above guidance on treatment duration should be followed.
8 mg/kg (up to a maximum of 50 mg per dose) once weekly. There is generally no applicable use of etanercept in children aged below 6 years in the indication plaque psoriasis. 6). Comprehensive instructions for administration are given in the package leaflet, section 7, “Instructions for use”.
Detailed instructions on unintentional dosing or scheduling variations, including missed doses, are provided in section 3 of the package leaflet.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised May 28, 2026[3]
Summary of the safety profile The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), headache, allergic reactions, development of autoantibodies, itching, and fever.
Serious adverse reactions have also been reported for etanercept. TNF-antagonists, such as etanercept, affect the immune system and their use may affect the body’s defenses against infection and cancer. Serious infections affect fewer than 1 in 100 patients treated with etanercept.
Reports have included fatal and life-threatening infections and sepsis. Various malignancies have also been reported with use of etanercept, including cancers of the breast, lung, skin and lymph glands (lymphoma). Serious haematological, neurological and autoimmune reactions have also been reported.
These include rare reports of pancytopenia and very rare reports of aplastic anaemia. Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with etanercept use. There have been rare reports of lupus, lupus-related conditions, and vasculitis.
Tabulated list of adverse reactions The following list of adverse reactions is based on experience from clinical trials in adults and on post - marketing experience. Within each System Organ Class, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
4) Respiratory, thoracic, and mediastinal disorders Interstitial lung disease (including pneumonitis and pulmonary fibrosis)* System Organ Class Very Common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very Rare <1/10,000 Not Known (Cannot be Estimated from Available Data) Gastrointestinal disorders Inflammatory bowel disease Hepatobiliary disorders Elevated liver enzymes* Autoimmune hepatitis* Skin and subcutaneous tissue disorders Pruritus, rash Angioedema, psoriasis (including new onset or worsening and pustular, primarily palms and soles), urticaria, psoriasiform rash Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions Toxic epidermal necrolysis Musculoskeletal and connective tissue disorders Cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus, lupus-like syndrome Renal and urinary disorders Glomerulonephritis General disorders and administration site conditions Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)* Pyrexia * see Description of selected adverse reactions, below.
16 Description of selected adverse reactions Malignancies and lymphoproliferative disorders One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with etanercept for up to approximately 6 years, including 231 patients treated with etanercept in combination with methotrexate in the 2-year active controlled study.
The observed rates and incidences in these clinical trials were similar to those expected for the population studied. A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 etanercept-treated psoriatic arthritis patients.
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in etanercept-treated patients. 5 […]
EUOfficial regulatory label· Warnings and precautions· revised May 28, 2026[3]
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Patients should be evaluated for infections before, during, and after treatment with Fubelv, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 6 to 300 hours).
8). These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa). In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death.
, exposure to endemic mycoses) should be considered. Patients who develop a new infection while undergoing treatment with Fubelv should be monitored closely. Administration of Fubelv should be discontinued if a patient develops a serious infection.
Physicians should exercise caution when considering the use of Fubelv in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections, such as advanced or poorly controlled diabetes.
Tuberculosis Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with etanercept. Before starting treatment with Fubelv, all patients must be evaluated for both active and inactive (‘latent’) tuberculosis.
This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy. , tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
It is recommended that the conduct of these tests should be recorded in the Patient Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
If active tuberculosis is diagnosed, Fubelv therapy must not be initiated. If inactive (‘latent’) tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Fubelv, and in accordance with local recommendations.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised May 28, 2026[3]
1. Sepsis or risk of sepsis. Treatment with Fubelv should not be initiated in patients with active infections, including chronic or localised infections.
This is not medical advice. Consult a qualified healthcare professional.
In this situation, the benefit/risk balance of Nepexto therapy should be very carefully considered. , persistent cough, wasting/weight loss, low-grade fever) appear during or after Nepexto treatment. Hepatitis B reactivation Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including etanercept, has been reported.
This includes reports of reactivation of hepatitis B in patients who were anti-HBc positive but HBsAg negative. Patients should be tested for HBV infection before initiating treatment with Nepexto. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Caution should be exercised when administering Nepexto in patients previously infected with HBV. These patients should be monitored for signs and symptoms of active HBV infection throughout therapy and for several weeks following termination of therapy.
Adequate data from treating patients infected with HBV with anti-viral therapy in conjunction with TNF- antagonist therapy are not available. In patients who develop HBV infection, Nepexto should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Worsening of hepatitis C There have been reports of worsening of hepatitis C in patients receiving etanercept. Nepexto should be used with caution in patients with a history of hepatitis C. Concurrent treatment with anakinra Concurrent administration of etanercept and anakinra has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone.
This combination has not demonstrated increased clinical benefit. 8). Concurrent treatment with abatacept In clinical studies, concurrent administration of abatacept and etanercept resulted in increased incidences of serious adverse events.
5). Allergic reactions Allergic reactions associated with etanercept administration have been reported commonly. Allergic reactions have included angioedema and urticaria; serious reactions have occurred. If any serious allergic or anaphylactic reaction occurs, Nepexto therapy should be discontinued immediately and appropriate therapy initiated.
Immunosuppression The possibility exists for TNF-antagonists, including etanercept, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses. In a study of 49 adult patients with rheumatoid arthritis treated with etanercept, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
Two juvenile idiopathic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae. Patients with a significant exposure to […]
In this situation, the benefit/risk balance of ENBREL therapy should be very carefully considered. Anti-tuberculosis therapy should also be considered prior to initiation of ENBREL in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection.
Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient. Patients should be monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Tests for latent tuberculosis infection may be falsely negative while on therapy with ENBREL. Tuberculosis should be strongly considered in patients who develop a new infection during ENBREL treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis.
Histoplasmosis and other invasive fungal infections are not consistently recognized in patients taking TNF-blockers, including ENBREL. This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients who reside or travel in regions where mycoses are endemic, invasive fungal infection should be suspected if they develop a serious systemic illness.
Appropriate empiric antifungal therapy may be initiated while a diagnostic workup is being performed. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. When feasible, the decision to administer empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment of invasive ENBREL Product Monograph Page 10 of 85 fungal infections and taking into account both the risk for severe fungal infection and the risks of antifungal therapy.
ENBREL should be discontinued if a patient develops a serious infection or sepsis. A patient who develops a new infection during treatment with ENBREL should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and antimicrobial therapy should be initiated, as appropriate.
In post-marketing studies of patients with JIA, serious infections have been reported in approximately 3% of patients. 8%). General Parenteral administration of any biologic product should be attended by appropriate precautions in case an allergic or untoward reaction occurs.
Allergic reactions associated with administration of ENBREL during clinical trials have been reported in < 2% of patients. If any serious allergic or anaphylactic reaction occurs, administration of ENBREL should be discontinued immediately and appropriate therapy initiated.
Concurrent ENBREL and anakinra treatment Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and ENBREL with no added clinical benefit compared to ENBREL alone. Because of the nature of the adverse events seen with combination of ENBREL and anakinra therapy, the combination of ENBREL and anakinra is not recommended (see DRUG INTERACTIONS).
Concurrent ENBREL and abatacept treatment In clinical studies, concurrent administration of […]
In this situation, the benefit/risk balance of Fubelv therapy should be very carefully considered. , persistent cough, wasting/weight loss, low-grade fever) appear during or after Fubelv treatment. Hepatitis B reactivation Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including etanercept, has been reported.
Patients should be tested for HBV infection before initiating treatment with Fubelv. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Caution should be exercised when administering Fubelv in patients previously infected with HBV.
These patients should be monitored for signs and symptoms of active HBV infection throughout therapy and for several weeks following termination of therapy. Adequate data from treating patients infected with HBV with anti-viral therapy in conjunction with TNF- antagonist therapy are not available.
In patients who develop HBV infection, Fubelv should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. 7 Worsening of hepatitis C There have been reports of worsening of hepatitis C in patients receiving etanercept.
Fubelv should be used with caution in patients with a history of hepatitis C. Concurrent treatment with anakinra Concurrent administration of etanercept and anakinra has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone.
This combination has not demonstrated increased clinical benefit. 8). Concurrent treatment with abatacept In clinical studies, concurrent administration of abatacept and etanercept resulted in increased incidences of serious adverse events.
5). Allergic reactions Allergic reactions associated with etanercept administration have been reported commonly. Allergic reactions have included angioedema and urticaria; serious reactions have occurred. If any serious allergic or anaphylactic reaction occurs, Fubelv therapy should be discontinued immediately and appropriate therapy initiated.
Immunosuppression The possibility exists for TNF-antagonists, including etanercept, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses. In a study of 49 adult patients with rheumatoid arthritis treated with etanercept, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
Two juvenile idiopathic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae. Patients with a significant exposure to varicella virus […]